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| Name | Class |
|---|---|
| Samsung | INDUSTRY |
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The purpose of this study is to collect body composition data using bioimpedance analysis (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5 of this consent. The data collected will help Samsung improve the products the company offers.
If you are eligible and you choose to participate in this study, you will be asked to come to the Bone & Joint Clinic of Baton Rouge in Baton Rouge between 7:00 and 11:00 am after at least a two-hour fast (nothing to eat or drink besides water for 2 hours prior to your appointment). You will be asked not to exercise, shower, or use a steam room or sauna at least two hours prior to evaluation. The study visit will take approximately one hour. During the visit, you will complete the informed consent process and then complete the baseline body measurements and body composition procedures immediately afterwards. Adult pre-menopausal women will have a urine pregnancy test prior to evaluation. Study procedures are not for diagnostic or treatment purposes and the DXA scan is intended for research purposes.
Description of study procedures
Body Measurements (about 15 minutes):
A series of body measurements will be taken by trained staff. These measurements include height, weight, and vital signs. The weight and height measurements will be completed twice during this time. The subject will wear a hospital gown and tight fitting garments for these procedures and the subject's BMI will be calculated from these measurements.
Body Composition Measurements
Whole Body DXA Scan, about 20 minutes This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. The subject will be required to wear a hospital gown, to remove all metal-containing objects from the body, and to lie down on the table. The subject will be carefully positioned on the table, and the legs will be placed together using two Velcro straps. A scanner emitting low energy X-rays and a detector will pass along the body. The subject will be asked to remain completely still while the scan is in progress. The scan takes approximately ten minutes.
Impedance Analysis (BIA) (about 10 minutes):
These tests will measure the amount of fat in the body. These procedures will vary depending on the measurement system and several different BIA systems will be used during this test.
Some examples are presented in the supplementary material at the end of this protocol.
Specifically, the following systems will be used in this study:
Samsung Health Cover; Measure 3 times; Standing Posture
Marketed systems:
InBody720 (http://www.biospaceamerica.com/Product/ib720.html; measure one time; Standing Posture Omron 306; Measure 1 time; Standing Posture Omron 510; Measure 1 time; Standing Posture
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 10-17 | Participants age 5 - 17 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) |
| |
| Age 18-80 | Age 18-80 years Participants age 18-80 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Measurements | Other | A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment | The study will be conducted in two overlapping phases. In Phase I, approximately 300 adult subjects (>18 to 80 yrs, equal numbers of female and male) will be recruited to take part in this study as detailed below: (1) Underweight (BMI<18.5 k/m2), 50 subjects. (2) Normal-Overweight (18.5-30), 150 subjects. (3) Obese (>30), 100 subjects. Phase II, planned to start later this spring and summer, will involve evaluation of children and 100 subjects (10-</=18 yrs, equal numbers of female and male) are planned in this phase as: (1) Normal-Overweight (18.5-30), 50 subjects. (2) Obese (>30), 50 subjects. An addendum describing details of this study phase will be forthcoming. Informed consent for both adults and children will be obtained for this study. Written and verbal assents for children will be obtained for this study. | First Visit (Only one visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Improve the BIA body composition predictions using circumference and tissue thickness measurements | Part II: Verify developed algorithms:
| First Visit (Only one visit) |
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Inclusion Criteria:
Exclusion Criteria:
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Male or Female age 10-80 years of age.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D001837 | Body Weights and Measures |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Whole Body DXA Scan | Other | This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table. |
|
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| Bioelectrical Impedance Analysis (BIA) | Other | These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will also hold on to hand electrodes for three other BIA systems. |
|
|
| Bioelectrical Impedance Analysis (BIA) | Other | These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. You will be asked to hold on to hand electrodes on a hand hold device. You will be asked to complete 3 measurement (less than one minute). You will also hold on to hand electrodes for two other BIA systems. |
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| add name here | Other |
|
| D000886 |
| Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |